drugset / Trial / NCT00197275

Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants

NCT00197275

Phase 3 Completed 800 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindPrevention

Summary

The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.

Timeline

Start
2006-02
Primary completion
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Hib-MenAC Vaccine
Subject Tritanrix-HepB Vaccine